New · posted Nov 8
Thermo Fisher Scientific · Pharmaceuticals
Staff Validation Engineer, Media Fills
- Greenville, NC
- On-site
- Full-time
- Senior & Principal
What you need
Education
- Bachelor’s degree in Engineering, Life Sciences, or related field
Experience
- 8+ years of experience in pharmaceutical/biotech validation
- Strong experience with aseptic processing and media fill execution (required)
- Experience in sterile manufacturing environments (required)
Knowledge, Skills, Abilities
- Deep understanding of aseptic processing and contamination control
- Strong knowledge of cGMP and regulatory expectations
- Technical writing expertise (validation protocols and reports)
- Ability to lead complex validation projects independently
- Strong collaboration and communication skills
What you'll do
How will you make an impact?
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. The Staff Engineer, Media Fill plays a critical role in supporting sterile/aseptic manufacturing operations by leading media fill (aseptic process simulation) programs. This role ensures processes remain in a validated state and compliant with global regulatory expectations.
What will you do?
- Lead the design and execution of media fill (APS) studies for aseptic manufacturing processes
- Author and review validation protocols, reports, and risk assessments
- Support investigations, deviations, and CAPAs related to media fills and aseptic processes
- Partner cross-functionally with Manufacturing, Quality, and Regulatory teams
- Ensure compliance with cGMP, FDA, EMA, and global regulatory requirements
- Drive continuous improvement initiatives in validation and contamination control strategies
Where you'll work
Greenville, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Greenville, NCWorking conditions
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in North Carolina6 roles publishing pay
Senior & Principal roles in the US36 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| North Carolina (middle half) | $99,500 | $117,500 | $149,000 |
| All US (middle half) | $105,250 | $123,250 | $139,375 |
Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 98 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 16 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification6
- Collaboration and leadership5
- GMP and compliance2
- Documentation and SOPs2
- Quality systems and risk2
- Clinical trial conduct2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Validation & CQV work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- ASTMASTM E2500(official source, opens in a new tab)Specification, design and verification of pharmaceutical manufacturing systems and equipment
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 118
- Open roles
- 118
- Distinct roles
- 51
- Locations
By discipline
- Quality74 60%
- Clinical43 35%
- Regulatory6 5%
By level
- Senior & Principal56 46%
- Associate & Specialist36 29%
- Manager25 20%
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Staff Validation Engineer, Media Fills at Thermo Fisher
Open until filled.